Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Ocular Hypertension Clinical Trial

Official title:

Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069706
• Other study ID #: C-03-25
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2003
• Last updated: February 11, 2012
• Start date: July 2003
• Est. completion date: October 2003

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older.

• Diagnosis of open-angle glaucoma or ocular hypertension.

• LogMAR visual acuity not worse than 0.6.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Clinically relevant ophthalmic or systemic conditions.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• AL-12182 0.003% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Other:
• AL-12182 Ophthalmic Solution Vehicle
Placebo

Drug:
• Latanoprost 0.005% Ophthalmic Solution
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
• AL-12182 0.01% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
• AL-12182 0.03% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP)